GSK to supply more than 400 million doses of swine flu vaccine

LONDON GlaxoSmithKline has contracts to supply more than 400 million doses of vaccine for the H1N1 swine flu, the British drug maker announced.

GSK said Tuesday that it had received orders for 149 million additional doses of the vaccine, bringing the total to 440 million. The company plans to ship initial supplies of the vaccine this week and into the first half of 2010.

Doses of the vaccine have been percolating into various parts of the United States over the last several days, and Health and Human Services secretary Kathleen Sebelius recently said that Americans “must” get the vaccine. To date, the pandemic H1N1 flu has killed about 600 people in this country.

FDA unanimously recommends GSK’s kidney cancer treatment

PHILADELPHIA A Food and Drug Administration advisory committee has recommended approval for a new kidney cancer drug.

GlaxoSmithKline announced that the FDA’s Oncologic Drugs Advisory Committee had voted unanimously to recommend approval for Votrient (pazopanib), an investigational pill-based treatment for renal cell carcinoma.

“Kidney cancer is a very serious disease, therefore the committee’s recommendation in support of pazopanib is an important step towards bringing a new, oral treatment option to advanced renal cell cancer patients,” GSK VP oncology research and development Rafael Amado said in a statement. “We look forward to working with the FDA towards the approval of pazopanib.”

The committee based its decision based on a phase 3 trial presented at the American Society of Clinical Oncology’s annual meeting this year. FDA advisory committees’ recommendations don’t guarantee full FDA approval, but are taken into account when the agency decides whether to approve a drug.

Generic drug combination cuts heart attack, stroke risk, study finds

OAKLAND, Calif. Combining two cheap generic drugs prevented more than 1,000 heart attacks and strokes, according to a study by Kaiser Permanente.

According to the study, published in The American Journal of Managed Care, 68,560 patients with diabetes or heart disease received daily 40 mg doses of the cholesterol-lowering drug lovastatin and 20 mg of the blood pressure-lowering drug lisinopril daily for three years. The combination of the drugs lowered their risk of hospitalization due to heart attack or stroke after two years by more than 60%, the study found.

It is also assumed that 75% of study participants were also taking aspirin, though aspirin was not included in the study because it is an OTC drug, and its use could not be measured through pharmacy records.

“Heart disease is the No. 1 killer in the United States, and 23 million Americans have diabetes,” Kaiser Permanente Care Management Institute diabetes clinical lead and lead study author R. James Dudl said in a statement. “This is a proven program that can be applied in many settings to reduce heart attacks and strokes, and at the same time decrease the cost of care for those events.”

The study followed 170,024 Kaiser Permanente members in California with heart disease or diabetes, dividing them into three groups: a high-exposure group of 21,292 who took the two drugs more than half of the time and 2004 and 2005 based in prescription refill habits; a low-exposure group of 47,268 who took them less than half the time; and a group of 101,464 people who didn’t take the drugs. Among the whole study population, there were 21 heart attacks per 1,000 people in 2006, but among the patients who took the drugs, there were 545 to 726 fewer heart attacks than among those who did not take the drugs.

Lovastatin is the generic version of Merck & Co.’s Mevacor, approved by the Food and Drug Administration in 1987. Lisinopril is the generic version of Merck’s Prinivil, approved the same year.

RELATED NEWS

The Food and Drug Administration has approved a generic of Hoffman-La Roche’s Tamiflu (oseltamivir phosphate) capsules from Lupin. The company’s generic will be available in 30-, 45- and 75-mg dosage strengths.
The product is inficated to treat acute, uncomplicated influenza A and B in patients 2 weeks of age and older, as well as to prevent influenza A and B in patients 1 year old and older. The drug had U.S. sales of roughly $467.8 million for the 12 months ended October 2017, according to IQVIA data.

Behavioral health pharmacy and telepsychiatry company Genoa, a QoL Healthcare Company, has reached a big number with its remote psychiatry offering. The Tukwila, Wash.-based company announced Tuesday that it had facilitated more than 100,000 telepsych consultations on its video conferencing platform.
Genoa attributes the milestone to its recent buildup of its telepsychiatry operations, which grew to include 35 in 2017 from 20 at the start of the year, and included 250 providers. In 2017, the company grew to serve more than 2,500 patients per week.

This year's flu continues to be Texas big, according to the Walgreens Flu Index released Wednesday, as the top 10 communities experiencing the greatest amount of flu incidence were all located in the Lone Star State for the week ended Jan. 6.
Iowa, Idaho and Arkansas rank behind Texas in terms of flu activity. And Montana, Idaho and Iowa ranked highest among states experiencing flu activity gains.

Amneal Biosciences has launched its generic of Otsuka’s Busulfex (busulfan injection, 6 mg/ml). The product is indicated to treat chronic myelogenous leukemia.
Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.
The drug had U.S. sales of roughly $80 million for the 12 months ended October 2017, according to data from IQVIA.

Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:

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